Rapid Acclimatization to Hypoxia at Altitude

October 23, 2014 updated by: Christopher Bell, Colorado State University
In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.

Study Overview

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Fort Collins, Colorado, United States, 80523-1582
        • Colorado State University, Dept. of Health and Exercise Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normotensive (i.e. <140/90 mmHg)

Exclusion Criteria:

  • Pregnancy
  • nursing mother
  • current tobacco use or regular use within the previous two years
  • use of prescription medication other than birth control
  • asthma or any other type of lung/respiratory dysfunction
  • resting oxygen saturation <95%
  • unwillingness to abstain from exercise for 48 hours prior to laboratory testing
  • use of anticoagulant therapy or have a known or suspected bleeding disorder
  • identification of contraindication during screening (i.e. positive stress test)
  • any history of mountain sickness (altitude sickness)
  • any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives
  • history of clinically significant illness within 4 weeks prior to Day 1
  • Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1
  • receipt of a transfusion or any blood products within 30 days prior to visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo

Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.

Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.

Yellow corn meal in gel capsules
Other Names:
  • Yellow corn meal
ACTIVE_COMPARATOR: Aminophylline

Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.

Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.

National Drug Code (NDC) 0143-1020-01
Other Names:
  • Theophylline
ACTIVE_COMPARATOR: Methazolamide

Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.

Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.

NDC 0781-1072-01
Other Names:
  • Neptazane
ACTIVE_COMPARATOR: Aminophylline+Methazolamide

Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)

Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.

NDC 0143-1020-01 and NDC 0781-1072-01
Other Names:
  • Theophylline + Neptazane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
Time Frame: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (ESTIMATE)

October 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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